Diabetes Dialogue: INHALE-3 and Diabetes Tech Updates, with Grazia Aleppo, MD

At the 84th American Diabetes Association (ADA) Scientific Sessions, INHALE-3 was among the trials to take center stage.

A phase 4 trial comparing the use of inhaled insulin (Afrezza) against standard care, results demonstrated use of inhaled insulin, in addition to insulin degludec, was associated with improved HbA1c in patients with type 1 diabetes, with an improvement of 0.5% or greater observed among 21% of those on inhaled insulin and 5% of those with usual care.

At the meeting, study investigator Grazia Aleppo, MD, professor of Medicine and director of the Diabetes Center at Northwestern University, joined Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, for a discussion on the trial, results, considerations for practicing clinicians, and next steps for research. In the latter portion of the episode, Aleppo, who serves on the guideline writing committee for the ADA Standards of Care discusses recent updates in diabetes technology.

INHALE-3

A phase 4 trial, INHALE-3 was designed with a 17-week randomized period and a 13-week extension period to assess the efficacy and safety of inhaled insulin plus degludec insulin against standard of care in patients with type 1 diabetes. The trial randomized 123 adult patients to inhaled insulin plus degludec insulin or usual care.

Initial analysis demonstrated use of inhaled insulin was associated with significant improvement in HbA1c levels relative to usual care. Further analysis demonstrated an improvement of 0.5% or greater was observed among 21% of those on inhaled insulin and 5% of those with usual care.

Overall, 30% of the inhaled insulin group and 17% of the usual care group achieved an HbA1c less than 7% at week 17. Among participants with an HbA1c level of 7% or greater at baseline, 21% of the inhaled insulin cohort achieved the HbA1c goal of less than 7%. Of note, 0 patients in the usual care group meeting these criteria achieved an HbA1c goal of less than 7%.

Relevant disclosures for Aleppo include CogniMed, Inc, DexCom, Inc, HealthLogiX, LLC, Insulet Corporation, and Tarsus Cardio, Inc. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

References:

1. ^{Hirsh I. The Efficacy and Safety of Inhaled Insulin Used with Insulin Degludec Compared with Automated Insulin Delivery or Multiple Daily Insulin Injections in Adults with Type 1 Diabetes—Results of the INHALE-3 Randomized Trial. Presented at: American Diabetes Association (ADA) 84th Scientific Sessions. June 21 - 24, 2024. Orlando, FL.}
2. ^{MannKind Corporation. Inhale-3 study reveals positive readout in head-to-head comparison of inhaled insulin vs. usual care in T1D; new data presented at American Diabetes Association’s 84th scientific sessions. MannKind Corporation. June 22, 2024. Accessed June 23, 2024. https://investors.mannkindcorp.com/news-releases/news-release-details/inhale-3-study-reveals-positive-readout-head-head-comparison.}